{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "192938", "product_res_number": "Z-1079-2022", "event_date_initiated": "2022-03-03", "event_date_created": "2022-05-13", "recall_status": "Open, Classified", "res_event_number": "89931", "product_code": "FDT", "k_numbers": [ "K193202" ], "product_description": "EXALT Model D Single- Use Duodenoscope (Box 1)\nUPN: M00542420 \n\nIntended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT\" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.", "code_info": "All lots\n\nGTIN: 08714729983514", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Rebecca KinKead Rubio \n508-683-4000", "reason_for_recall": "Updated Instructions for Use (IFU) for EXALT Model D\nSingle-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.", "root_cause_description": "Device Design", "action": "Boston Scientific notified US and US Territories from March 3rd through March 17th, via hand delivery, FedEx, or e-mail . OUS Consignees were notified from March 3rd through March 10th, via hand delivery, courier, or e-mail. Additional US Consignees located in the US and US Territories were notified from April 7, 2022, through April 13, 2022. Additional OUS Consignees were notified on April 7, 2022.\nImmediate Action Required EXALT Model D Single-Use Duodenoscope. Letter states. Customers to whom hand-delivery is not possible within a ten-day timeframe will receive the letter through other means (e.g., courier, e-mail). The notification instructs the account to review the content of the IFU updates, share the information and post it in a visible location near the product, and to complete the Acknowledgment Form to confirm receipt of the notification.\n\nAfter all applicable regulatory approvals are obtained, the updated IFUs will be\npackaged with EXALT Model D Single-Use Duodenoscopes. An updated IFU will be\navailable at https://www.bostonscientific.com/elabeling in the US.\n\n***UPDATE 4/29/22:\nBSC implemented the updated IFU for US customers (an electronic-only IFU published to\nBSC's website) on March 21 , 2022. This electronic-only IFU supports UPNs M00542420 and M00542421 (the UPNs intended primarily for US distribution).\nBSC will implement the updated IFU for OUS customers (in UPNs M0054242CE0 and\nM0054242CE1 , the UPNs intended primarily for OUS distribution) following language\ntranslations and receipt of paper IFU inventory, estimated for May 2022.", "product_quantity": "1486 units: US: 1,441; OUS: 45", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, \nBulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, \nNorway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, \nSweden, Switzerland, Taiwan, Unit. Arab Emir.", "openfda": { "k_number": [ "K161222", "K152257", "K203028", "K942338", "K163614", "K192280", "K253646", "K980465", "K202661", "K963056", "K192245", "K233886", "K182051", "K233942", "K193182", "K250701", "K110833", "K042076", "K181745", "K193202", "K092710", "K024033", "K202365", "K961568", "K251867", "K220587", "K191747", "K962212", "K832006", "K080403", "K201098", "K181522", "K210710", "K143153", "K251861" ], "registration_number": [ "3012843412", "3042225166", "3005099803", "3016497307", "3004638277", "1225984", "3010220595", "2032098", "3003637092", "3010273872", "1000121056", "3002807314", "2020550", "9610595", "9681260", "9611680", "3042172882", "2029011", "9610877", "3014605202", "3014055212", "9611112", "3006161756", "1220477", "3008386005", "8010047", "3003782610", "9616684", "3004040397", "9610691", "3010772972", "3007695959", "3010202439", "3017210488", "3011050570", "3009171251" ], "fei_number": [ "3012843412", "3042225166", "3005099803", "3008782585", "3002964398", "3016497307", "3004638277", "3002806359", "3010220595", "3002808127", "3003637092", "3010273872", "1000121056", "3002807314", "3002913962", "2020550", "3042172882", "3003058448", "3002806565", "3008185830", "3014605202", "3014055212", "1220477", "3008386005", "3003782610", "3004040397", "3002807795", "1000160571", "3007475226", "3002516162", "3010772972", "3007695959", "3006759904", "3017210488", "3011050570", "3002807969" ], "device_name": "Duodenoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }